Urinary incontinence device

ABSTRACT

A urinary incontinence device includes an occluding member, such as a tampon or plug, that is retained by magnetic forces acting between a support and magnetic inserts located adjacent the uretha. The inserts may be implanted or injected and hold the occluding member in place.

The present invention relates to a urinary incontinence device.

Urinary incontinence in the aged population is an enormous problem.Approximately 50% of the patients residing in nursing homes were placedthere because of problems with urinary incontinence. It is estimatedthat there are 20 million incontinent patients in the United Statesalone, and that only 10% of these people ever seek medical assistance.Sufferers from this condition can become social hermits because of thefear of accidents due to sudden loss of urine and the embarrassmentassociated with urine odours. Most patients have been convinced thatincontinence is a natural aging phenomenon and many wear protectivepadding. This arrangement is extremely primitive and demeaning for thepatients.

The majority of urinary incontinence occurs in the female. Recentlythere has been an increase in post prostatectomy incontinence, sinceradical prostate surgery has increased dramatically in the last fiveyears.

A distinction must be made as to whether the problem occurs in an activehealthy person or in someone who is institutionalized in either achronic care facility or in a nursing home. The treatment approacheswill necessarily be different. In the case of the institutionalizedperson suffering from urinary incontinence, they are often unable tohave any surgical procedure to correct their condition so thatnon-invasive (non-surgical) approaches are required. The common practicein most nursing homes at present is to have the patients fitted with anabsorbent diaper-like material. These antiquated arrangements accountfor the malodorous environment found in nursing homes as well as thehigh incidence of local skin problems due to the constant exposure tourine. For various reasons, most nursing homes will not accept patientswith catheters.

Many devices have been designed to deal with the problem of urinaryleakage and the various difficulties associated with the use of thesedevices are well known. The basic problem found in many of the femaleswith urinary incontinence is that there is a descent of the bladder neckand an associated wide open bladder neck and upper third of urethra, theso-called funnel-shaped urethra. To correct the incontinence withoutsurgery, one must have a device which either occludes the urethra orelevates the bladder neck and occludes the upper 1/2 of the urethra.Many of the proposed devices are designed to be placed in the vagina butretaining the device has been one of the main problems associated withtheir use. In an effort to increase the obstruction to the flow ofurine, various other techniques have been used. More recentlyperiurethral injections with various compounds have been used. Thepurpose of these injections is to obliterate the lumen of the urethraand thus reduce the urinary incontinence. Some of the substancesinjected include periurethral Teflon, injections of collagen and morerecently periurethral injections of autogous fat. In some instances,urethral catheterization has been used to control incontinence. Thiscarries a risk of significant infection. More recently, there have beenvarious urethral plugs designed for inserting in the urethra to occludethe lumen. These plugs are disposable and have to be re-inserted aftereach voiding. Some of the plugs are retained by means of a balloonarrangements and these all carry the risk of urethral irritation andinfection.

In summary, females are incontinent of urine for several reasons andthere are various classifications of the problem. As a generalobservation, the condition can be controlled by several non-surgicalapproaches. One can insert a urethral plug to retain the urine or adevice can be used to elevate the bladder neck and occlude the upperhalf of the urethra. This will restore continence in most instances.

In German Patent Application No. 3139811, there is described a device inwhich a magnetic plate is surgically attached to the pubic bone. Atampon containing a magnet is inserted into the vagina and it isintended that the magnetic force between the plate and magnet willocclude the urethra. Test results indicate that this procedure has notbeen successful in all instances, possibly because of the spacingbetween the plate and magnet. Moreover, it is clearly desirable for thetampon to be disposable so that the inclusion of the magnet renders theprocedure prohibitively expensive.

There have been other proposals to utilize magnetic attraction to retaina medical device, such as that shown in U.S. Pat. No. 4,154,226 or U.S.Pat. No. 3,952,726, both to Hennig, and U.S. Pat. No. 4,258,705 toSorenson but these have not specifically addressed devices that areintended to overcome the practical problems associated withincontinence.

U.S. Pat. No. 3,926,175 shows a mechanical device intended to supplementbladder control but requires surgical implantation about the neck of thebladder and the application of an external mechanism to open or closethe device. As such, its installation and operation is undulycomplicated.

A further device is shown in U.S. Pat. No. 2,649,086 which includes aresilient ring with a radial protrusion that is inserted in the vaginaand bears against the urethra. However, the careful placement of thisdevice is critical to its successful operation and its retention isdependent purely upon the resilience of the ring.

There are several basic requirements that must be satisfied in thedesign of these incontinent devices. The device must be held in placeand this applies whether the urethra is occluded internally or thebladder neck and upper urethra are occluded by a vaginal device. Ineither instance of the device, provision must be made for the bladder tobe emptied on a regular basis. In some circumstances it is preferablethat this should be done without having to remove the appliance. Thedevices presently available do not meet such requirements satisfactorilyand it is therefore an object of the present invention to obviate ormitigate the disadvantages present in such devices.

In general terms, the present invention provides an incontinence devicewhich may be positioned to occlude the urethra and is retained inposition by magnetic forces.

Although magnetic materials have had widespread industrial and domesticapplications. They have had limited application in the design ofbiomedical devices principally because they lost magnetic power whenimplanted. The discovery of rare earth magnets has opened up a new areafor biomedical research. These magnets containing neodymium boron andother compounds are readily available. Their attractiveness lies in thefact that they are up to 50 times stronger than the strongest ferrite oralnico magnets. The rare earth magnets are non-toxic and can be coatedwith biocompatible materials. This will allow them to be placed in thebody and they do not lose their magnetic properties when coated.

The preferred embodiment of devices to be described utilize the power ofthe neodymium magnets and the numerous biocompatible materials which areavailable to design effective anti-incontinence devices. To complete themagnetic attachment, metallic depots can be established in various areasin the tissues of the female pelvis by injecting metallic materialcoated with biocompatible compounds. During the last 10 years, there aremany reports of Teflon, collagen or fat being injected around thebladder neck and upper urethra in the female in an attempt to correcturinary incontinence. It is now possible to create metallic depots whichwill serve as anchoring stations for magnetic attachments of theincontinence devices. It is also possible to establish metallic depotsin the vagina without injection by means of a pasted or incorporatedinto a small tampon.

In one preferred embodiment, a malleable support is provided to retain atampon within the vagina. The support is retained by deposits ofmagnetic material injected into the vaginal wall and co-operating withmagnets carried by the support. Accordingly, the support can beconfigured to suit individual needs but is retained securely by themagnets. Preferably the tampon is disposable.

In an alternative embodiment, an incontinence device includes an outersheath to be secured within the urethra. A core is provided within thesleeve and is retained by magnetic forces between the sleeve and core.

Embodiments of the invention will now be described by way of exampleonly with reference to the accompanying drawings, in which

FIG. 1 is an elevation of a first embodiment of an incontinence device;

FIG. 2 is a side elevation of the device of FIG. 1;

FIG. 3 is a view showing the device of FIG. 1 installed in a female;

FIG. 4 is a side view of FIG. 3;

FIG. 5 is a view similar to FIG. 3 showing a second embodiment of thedevice installed in a male;

FIG. 6 is a side elevation of a further embodiment of an incontinencedevice;

FIG. 7 is an end view of the device of FIG. 6;

FIG. 8 is a side sectional view of a male urinary incontinence device;

FIG. 9 is a side view of an alternative embodiment of incontinencedevice for female use;

FIG. 10 is a view on the line X--X of FIG. 9; and

FIG. 11 is a side view similar to FIG. 9 of an alternative device.

Referring therefore to FIG. 1, an incontinence device 10 comprises aband 11 which has opposite ends folded back upon itself to define upperand lower arms 12, 14 respectively that are interconnected at oppositeends as indicated at 16. Each of the arms 12, 14 is formed from aflexible material that is rendered magnetic, either by a magneticcoating or by selection of the material used to manufacture the arms.Preferably the band 11 is malleable to permit "fitting" of the device10. The arms 12, 14 are covered by a biocompatible material, typically apolymer.

An occluding tampon 20 is located between opposed ends of upper arm 12and is supported by the central portion of lower arm 14. Notches 18 maybe formed in the side of the tampon 20 to locate the ends of arms 12.The tampon 20 has a convex upper surface 21 in section and is formed ofTeflon or other synthetic or natural material that is soft enough toconform to the urethra.

The tampon 20 is elongate, as seen in FIG. 2, and has a predefinedcurvature along its longitudinal axis to conform to the vaginal/urethralwall. Typically the curvature presents a concave upper generatrix. Thetampon 20 is resilient so as to provide a gentle lifting force at thedistal end when inserted. The resilience is provided either from thematerial of the tampon itself that is molded or formed with a predefinedcurvature or from a resilient insert, indicated at 23, that is coveredby the material of the tampon. The tampon 20 terminates in a bulbous tip25 that elevates the bladder neck when in position.

The device 10 is inserted into the vagina 22 to be located adjacent theintersection of the vaginal wall 24 and urethra 26. Magnetic inserts 28are located in the periurethral tissues on the opposite side of thevaginal wall 24. One of the inserts 28 or arms 12, 14 is magnetized andthe other is magnetizable so that there is a magnetic attraction betweenthe arms 12, 14 and the inserts 28. Assuming the inserts 28 aremagnetized, they apply sufficient force on the arms 12, 14 to retain thedevice 10 in the vagina. The tampon 20 is positioned adjacent theurethra 26 so that the convex upper face 21 occludes the urethra. Thedistal end of the tampon 20 engages the upper wall of the vagina 22 andits resilience and curvature elevates the bladder neck and therebyinhibits fluid flow through the urethra.

To vent the bladder, it is simply necessary to remove device 10 byovercoming the magnetic forces between inserts 28 and arms 12, 14 andthereby open the urethra. Alternatively, the tampon may be manipulatedto a position in which the urethra is not occluded and the tip 25 allowsthe bladder neck to fall to void the bladder.

The entire device 10 may be disposable or the band 11 may be reusablewith a replacement tampon 20.

The magnetic inserts 28 may be discrete implants of magnetized materialor may be localized deposits that are injected or otherwise placed inthe periurethral tissues including the adjacent soft tissues, urethrallumen, urethral wall or adjacent bony structures.

Naturally the inserts 28 could be magnetizable material and the armsformed from magnetized material, although it is believed thatpermanently magnetized implants are preferable. Rare earth magnets, suchas neodymium, are preferred for their enhanced magnetic properties.Magnetizable deposits may be provided by iron carbonyl powder dispersedin an injectable carrier.

Tampon 20 is effective not only to occlude the urethra but also toelevate the bladder neck which should be particularly effective toconnect urinary incontinence in females.

Notches 18 in the tampon ensure an accurate orientation of the tamponalthough alternative indicators or orienting arrangements may beutilized.

The device 10 may be modified for use in a male as shown in FIG. 5 inwhich like reference numerals will identify like components with asuffix a' added for clarity.

In FIG. 5, the inserts 28a are located in the scrotal and perineal skinat a location where the urethral lumen is essentially subcutaneous. Thearms 12a, 14a are dimensioned to cause the insert 20a to compress theurethral lumen 30. Tampon 20a is similar to that described abovealthough not elongate and is dimensioned to occlude the urethral lumen30 when applied and retained by inserts 28. Venting of the bladder isaccomplished as before by removal of the insert 10.

An alternative embodiment is shown in FIG. 6 with a suffix b' added forclarity to denote like components. In the embodiment of FIGS. 1-4, themagnetic inserts 28 are located in the vaginal wall adjacent theurethra. As an alternative, as shown in FIG. 6, the inserts 28b arecreated on a surface of the inferior ischiopubic ramus 40 of the pelvis42.

As seen in FIGS. 6 and 7, the device 10b includes a pair of arms 12b,each of which terminates in a foot 44. The foot 44 carries a permanentmagnet 46 which co-operates with respective metallic inserts 28b toretain the device 10b within the vagina.

The arms 12b, are malleable and may be made of lightweight metallicmaterials such as alloys of magnesium or the like or may be made fromnon-metallic polymer substances and coated with biocompatible materialas necessary.

The arms 12b are joined to one another by a bridge 48 that supports atampon 20b similar to that described above with reference to FIG. 2. Thetampon 20 may be secured releasably to the bridge 48 in a manner similarto that shown in FIG. 2 or may utilize a magnetic connection where asuitable magnetic insert is included in the tampon 20.

Device 10b may therefore be inserted in the vagina and retained by theinserts 28b so that the tampon 20 occludes the urethra and elevates thebladder neck.

Device 10b is removable as above for emptying the bladder but preferablytampon 20b will include an opening device that allows the bladder to beemptied without removal of the entire device.

The magnetic retention of an urethral plug is shown in FIG. 8 where likereference numerals are used to denote like components with a suffix c'added for clarity.

Device 10c is formed as a plug 32 of foam expandable material that isdimensioned to fit the urethral lumen. A retraction cord 34 is securedto one end of the plug 32 and its opposite end is coated with acircumferential metal band 36. The band 36 may be magnetized ormagnetizable.

The plug 32 is retained by magnetic inserts 28c disposed in the urethralwall either by discrete insertion or injection as preferred. Where theband is magnetized, the inserts are magnetizable and, conversely, whenthe inserts are magnetized, the band is magnetizable.

A urethral plug suitable for female use is shown in FIGS. 9 and 10 wherelike reference numerals denote like components with a suffix d' addedfor clarity.

The device 10d includes an outer sheath 50 intended to be inserted inthe urethra and typically 4.5 cm to 5 cm long. The length and diameterwill vary with the age group and condition of the patient. The sheath 50is formed from elastomeric or polymeric materials that are biocompatibleor have a biocompatible coating. The outer surface of sheath 50 may alsobe treated with biological agents that inhibit production of bacterialbiofilm. Magnetic strips 52 are incorporated into the sheath 50 that areat circumferentially spaced locations and are positioned to co-operatewith inserts 28d provided in the periurethral wall or vaginal wall.

A core 54 is dimensioned to be insertable in and occlude the sheath 50.A flange 56 is provided at the vaginal end of the core 54 to permitrotation of the core 54 in the sheath. The core 54 is of courseeffective to seal the sheath and inhibit egress from the bladder.

The core 54 may be retained by a mechanical locking device that islocked or unlocked by rotation of the core or may utilize magneticforces for retention as shown in FIGS. 9 and 10.

A magnetic strip 58 is incorporated into the outer surface of core 54and co-operates with the strips 52 in the sheath. Alignment of thestrips 52,58 provides a magnetic attraction to retain the core 54 androtation of the core 54 moves the strips out of alignment to release thecore.

In the device 10d, the character of the strips 52,58 and inserts 28d areselected to that effective magnetic interaction is obtained. Typically,the strips 52 will be magnetized and the inserts 28d and strips 58 willbe magnetizable. The converse may be selected although care should betaken with the polarity of the magnets.

The provision of the sheath 50 avoids the irritation that mightotherwise occur with repeated insertion and removal of the core in theurethra.

An alternative manner of retaining the sheath is shown in FIG. 11 wherea suffix e' is used to denote like components.

In the device 10e, the sheath 50e is retained by a folding tie bar 60hinged at one end of the sheath 50e. The tie bar 60 is relatively narrowso as not to occlude significantly the sheath and has living hingepoints indicated at 62. Hinge points 62 bias the tie bar 60 to lie flatperpendicular to the urethra so as to engage the bladder neck andinhibit removal of the sheath 50e. The tie bar 60 may be extended in thedirection of the sheath during insertion by application of a suitabletool along the axis of the sheath and upon release will return to theflat perpendicular orientation.

The core 54e is retained in the sheath 50e in a manner similar to thatnoted above allowing repeated removal and insertion.

I claim:
 1. A urinary incontinence device comprising an occluding memberhaving a body with an outer surface engagable with a urethral wall foroccluding the urethra, a retainer a support member detachably secured tosaid body and having a pair of laterally extending legs to cooperatewith said retainer adapted to be adjacent to said urethra, to maintainsaid body at an occluding location, said legs being malleable to permitadjustment of said body relative to said urethral wall, said retainerand said support member being maintained in operative relationship byapplication of magnetic force therebetween.
 2. A device according toclaim 1 wherein said body is curved to elevate a neck of a bladder whenin said occluding location.
 3. A device according to claim 1 whereinsaid retainer includes a subcutaneous magnetic insert.